(21 days)
Not Found
No
The document describes standard PACS and image analysis tools without mentioning AI or ML.
No
The device is described as software for image display, manipulation, quantification, and reporting, functioning as a PACS tool and a clinical application for oncology, rather than directly treating or diagnosing patients.
Yes
The device aids in the "quantification and reporting of digital medical images" and offers a "clinical application for oncology including lesion marking and analysis," which are activities typically associated with diagnosing or assisting in the diagnosis of medical conditions. While it is a PACS tool, its specific features like "lesion marking and analysis" go beyond simple archiving and communication to support clinical interpretation.
Yes
The device description explicitly states "The EXINI software provides trained health-care professionals and researchers with a software tool set..." and details its function as a software application running on a standard PC. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a tool for handling, displaying, manipulating, quantifying, and reporting digital medical images acquired from nuclear imaging and CT. It provides PACS tools and a clinical application for oncology, specifically lesion marking and analysis.
- Device Description: The device description reinforces the intended use, focusing on software tools for image management and analysis.
- Lack of mention of in vitro samples: There is no mention of the device being used to examine or analyze samples taken from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are specifically designed for this purpose.
- Focus on imaging data: The entire description revolves around the processing and analysis of medical images, which are acquired directly from the patient's body.
While the device is used in a clinical setting and aids in diagnosis and treatment planning, it does so by processing and analyzing in vivo imaging data, not in vitro samples.
N/A
Intended Use / Indications for Use
EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The EXINI software provides trained health-care professionals and researchers with a software tool set for acceptance, transfer, storage, image display, manipulation and quantification of digital medical images. The software is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT) modalities. The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for markup and analysis of bone lesions in bone scans. The software complies with the Digital Imaging and Communications in Medicine (DICOM 3) standard.
The software runs on a standard PC with Microsoft Windows operating system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
nuclear imaging (NM) and computed tomography (CT)
Anatomical Site
bone lesions (in bone scans)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals and researchers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The verification and validation (V&V) plan including definition of test methods and acceptance criteria was designed to ensure equivalent performance with the predicate device. The verification included software unit testing, integration testing and software system testing with functional testing of all software requirements. The validation process was performed to ensure that the system meets the user needs specification. The V&V test results showed that EXINI meets its intended use, user needs and software requirements. Clinical testing was not conducted to support this 510(k) submission. The non-clinical performance data concludes that the subject device has equal performance and raises no new questions of safety and effectiveness in comparison to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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510(k) Summary EXINI EXINI Diagnostics
Image /page/0/Picture/1 description: The image shows a scattering of small, dark, irregular shapes against a white background. The shapes are distributed across the frame, with some appearing more clustered than others. The overall impression is one of randomness and simplicity, with no clear pattern or structure emerging from the arrangement of the shapes.
Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters. The sequence appears to be "K122205". The characters are written in a simple, handwritten style, with varying stroke thicknesses.
510(k) Summary
AUG 15 2012
Submitter Information
| EXINI Diagnostics AB
Scheelevägen 19A
SE-223 70 Lund
| Sweden | |
|---|---|
| Contact Person: | Allison Scott |
| 317.569.9500 | |
| ascott@ansongroup.com | |
| Date: | June 6, 2012 |
| Trade Name: | EXINI |
| Common Name: | Picture Archiving and Communications System (PACS) |
| Classification Name(s): | System, Image Processing, Radiological |
| Classification Number: | 21 CFR 892.2050, LLZ |
Predicate Device(s)
| 510(k) Number | Device Name | Submitter Name |
|---|---|---|
| K111319 | IBIS Explorer and Markup Software | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Canadian Canada College of Children Comments of Children Come of | |
| MEDQIA |
Device Description
The EXINI software provides trained health-care professionals and researchers with a software tool set for acceptance, transfer, storage, image display, manipulation and quantification of digital medical images. The software is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT) modalities. The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for markup and analysis of bone lesions in bone scans. The software complies with the Digital Imaging and Communications in Medicine (DICOM 3) standard.
The software runs on a standard PC with Microsoft Windows operating system.
・・・・ -
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510(k) Summary EXINI EXINI Diagnostics
Intended Use(s)
EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.
Technological Characteristics
EXINI and the IBIS Explorer and Markup Software have similar technological characteristics in that they are both software devices that provide general PACS functions with DICOM compatibility and image display. Both devices use image processing techniques for segmentation of skeletal regions, normalization and hotspot contouring/segmentation. Both devices are semi-automatic in that they require a manual step (hotspot verification step) where the user reviews and edits the selection of hotspots that are used as input for quantitative analysis. Both devices perform quantitative analysis based on 2D ROI (regions of interests) measurements in wholebody bone scans.
Non-Clinical Performance Data
The verification and validation (V&V) plan including definition of test methods and acceptance criteria was designed to ensure equivalent performance with the predicate device. The verification included software unit testing, integration testing and software system testing with functional testing of all software requirements. The validation process was performed to ensure that the system meets the user needs specification. The V&V test results showed that EXINI meets its intended use, user needs and software requirements.
Clinical Performance Data
Clinical testing was not conducted to support this 510(k) submission.
Non-Clinical and Clinical Performance Data Conclusions
The non-clinical performance data concludes that the subject device has equal performance and raises no new questions of safety and effectiveness in comparison to the predicate device.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
AUG 15 2012
EXINI Diagnostics AB % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K122205
Trade/Device Name: EXINI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 24, 2012 Received: July 25, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally is to (1) person is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tot use stated in the encrosure) to regars) activent date of the Medical Device Amendments, or to commerce province to May 20, 1976, the encordance with the provisions of the Federal Food. Drug, de vices that nave been require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The T ou thay, therefore, thanket the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is classified (sec above) into enas frecting your device can be found in Title 21, additional controls. Existing major regerances and to 895. In addition, FDA may publish further Sode of recents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination and any of the ot that FDA has made a determination that your device complies with other requirements of the Act that TDA has made a determination administered by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 Comply with an the Fict 5 requirements 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requireneuls as set forut in the quality of come ( > ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = will anow you to begin marketing your averalence of your device to a legally marketed notification. The FDA imania of successification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice of In Vitro Diagnostic Device Eyaluation and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device of to remarket 607), please connect the regulation entitled, "Misbranding by reference to premarket 5450. Also, prease note the regulation vialers, "For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDR regulation (21 CFR Pat 003), products good on default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtail other geleral mionmation on Jour Food Food and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: EXINI
Indications for Use:
EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
Division Sign-Off Devices
Division of Radiological Devices